Infections from Drug Vials on the Rise
Written by Faith Anderson on July 17, 2012
Re-Use of Drug Vials Due to Drug Shortages
One of two recent infection cases surfaced in Arizona in April 2012, and involved at least three patients who were diagnosed with MRSA infections after receiving outpatient treatment at a pain management clinic. A second case occurred in Delaware in March 2012, when at least seven patients were hospitalized with evidence of bursitis and septic arthritis after receiving joint injections from the same outpatient clinic. According to a recent report featured in the U.S. Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report, federal health officials have suggested that, in both instances, clinicians reported a difficulty obtaining the vial size or medication type they needed, resulting in their attempt to reuse single-dose vials on multiple patients. Since 2007, which is the year that injection safety was included as a component in Standard Precautions, at least 20 infection outbreaks have been linked to the inappropriate use of single-use or single-dose drugs on more than one patient.
Do CDC Guidelines Cause Drug Shortages?
The recent CDC report outlines the importance of adhering to U.S. Pharmacopeia standards for safe injection practices, in order to avoid infection transmission and to reduce the risk of adverse side effects caused by multi-patient use of single-dose medication vials. According to the CDC, drugs labeled as “single-dose” or “single-use” should be only used in that way, as life-threatening infections may result from medications being contaminated by multiple uses. Concerns have been raised however, about whether these CDC guidelines contribute to drug shortages and increased medical costs for healthcare providers.
U.S. Drug Shortages on the Rise
According to an FDA report released last year, the number of drug shortages has tripled from 61 in 2005 to 178 in 2010. Of the 127 drug shortages studied from 2010 to 2011, sterile injectables accounted for the majority, at 80%. The major therapeutic classes of drugs affected by shortages included oncology drugs (28%), antibiotics (13%) and electrolyte/nutrition drugs (11%). The FDA report also indicates that the primary causes of shortages reported to the agency were problems at the manufacturing facility (43%), delays in shipping or manufacturing (15%), and active pharmaceutical ingredient shortages (10%). Shortages caused by problems with manufacturing quality can involve serious issues, including the presence of metal filings, glass shards, and the contamination of products intended for injection in patients.